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辛酸甘氨酸和大豆异黄酮治疗多毛症:一项实验性和安慰剂对照的临床研究。

Capryloyl glycine and soy isoflavonoids in hypertrichosis: An experimental and placebo-controlled clinical study.

作者信息

Barbareschi Mauro, Benetti Federico, Gaio Elisa, Angileri Luisa, Veraldi Stefano

机构信息

Department of Pathophysiology and Transplantation, Università degli Studi, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

European Center for the Sustainable Impact of Nanotechnology (ECSIN), ECAMRICERT SRL, Padova, Italy.

出版信息

J Cosmet Dermatol. 2021 Apr;20 Suppl 1(Suppl 1):18-22. doi: 10.1111/jocd.14096.

DOI:10.1111/jocd.14096
PMID:33934471
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8252421/
Abstract

BACKGROUND

The management of acquired hypertrichosis (HT) is based on the search of the causes and subsequent specific treatment. However, simultaneous hair removal is important. No single method for hair removal is appropriate for all patients and skin areas. Treatment options are actually limited and clinical results are often unsatisfactory. Ornithine decarboxylase 1 (ODC1), an enzyme present in hair follicles, is considered as a potential target to inhibit hair growth. Only eflornithine hydrochloride, an inhibitor of ODC1, showed to be partially effective in the management of acquired HT.

AIMS

The aim of our study was to evaluate the potential inhibition of ODC1 activity by a cream containing 4% capryloyl glycine, an ODC1 inhibitor, and 1% glycine soy-fermented extract (soy isoflavonoids). Furthermore, we present the results of a placebo-controlled clinical study that evaluated the efficacy and tolerability of this cream.

METHODS

The ODC1 activity was detected by measuring absorbance at 340 nm. In the presence of ODC1 inhibitors, absorbance decreases as a function of inhibition. Difluoromethylornithine (DFMO) was provided as an inhibitor control. ODC1 activity inhibition was expressed as percentage of control (untreated sample). All data were presented as mean ± standard deviation of three independent experiments. To determine if statistically significant differences between treatments were present, a t test analysis was performed. The differences between groups were considered significant at p < 0.05. Twelve Caucasian female adult patients, with HT located on the forearms, were enrolled. The study cream (product A) was applied twice/day for four months on the right forearm. A placebo cream (product B) was applied twice/day for four months on the left forearm. Clinical efficacy was evaluated by means of macrophotography.

RESULTS

The cream significantly inhibited ODC1 activity (35.1 ± 0.5% inhibition, equivalent to a 64.9 ± 0.5% ODC1 activity). DFMO completely abolished the enzymatic activity (100 ± 5% inhibition, equivalent to 0 ± 5% ODC1 activity). All patients were considered evaluable. In 11 out of 12 patients (91.7%), who were treated with product A, an improvement was observed. No improvement was observed in patients treated with product B. The global assessment showed good efficacy in 7 patients (58.3%) and moderate efficacy in 5 patients (41.7%) treated with the product A. No efficacy was detected in patients treated with product B.

CONCLUSIONS

The study cream showed to be effective in Caucasian, adult, female patients with hypertrichosis located on the forearms.

摘要

背景

获得性多毛症(HT)的治疗基于病因查找及后续的特异性治疗。然而,同步进行脱毛也很重要。没有一种单一的脱毛方法适用于所有患者和皮肤区域。实际上,治疗选择有限,临床效果往往不尽人意。鸟氨酸脱羧酶1(ODC1)是一种存在于毛囊中的酶,被认为是抑制毛发生长的潜在靶点。只有ODC1抑制剂盐酸依氟鸟氨酸在获得性HT的治疗中显示出部分疗效。

目的

我们研究的目的是评估一种含有4%辛酰甘氨酸(一种ODC1抑制剂)和1%大豆发酵提取物(大豆异黄酮)的乳膏对ODC1活性的潜在抑制作用。此外,我们还展示了一项安慰剂对照临床研究的结果,该研究评估了这种乳膏的疗效和耐受性。

方法

通过测量340nm处的吸光度来检测ODC1活性。在存在ODC1抑制剂的情况下,吸光度会随着抑制作用而降低。提供二氟甲基鸟氨酸(DFMO)作为抑制剂对照。ODC1活性抑制率以对照(未处理样品)的百分比表示。所有数据均表示为三个独立实验的平均值±标准差。为了确定各治疗组之间是否存在统计学上的显著差异,进行了t检验分析。当p<0.05时,组间差异被认为具有显著性。招募了12名前臂患有HT的白种成年女性患者。将研究乳膏(产品A)每天两次涂抹于右前臂,持续四个月。将安慰剂乳膏(产品B)每天两次涂抹于左前臂,持续四个月。通过 macrophotography评估临床疗效。

结果

该乳膏显著抑制了ODC1活性(抑制率为35.1±0.5%,相当于ODC1活性为64.9±0.5%)。DFMO完全消除了酶活性(抑制率为100±5%,相当于ODC1活性为0±5%)。所有患者均被认为可评估。在使用产品A治疗的12名患者中有11名(91.7%)观察到有改善。使用产品B治疗的患者未观察到改善。总体评估显示,使用产品A治疗的患者中,7名(58.3%)疗效良好,5名(41.7%)疗效中等。使用产品B治疗的患者未检测到疗效。

结论

该研究乳膏对前臂患有多毛症的白种成年女性患者有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/d4115886084b/JOCD-20-18-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/76aad8814d83/JOCD-20-18-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/6b5738f628dc/JOCD-20-18-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/a2954e36d1d8/JOCD-20-18-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/d4115886084b/JOCD-20-18-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/76aad8814d83/JOCD-20-18-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/6b5738f628dc/JOCD-20-18-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/a2954e36d1d8/JOCD-20-18-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2944/8252421/d4115886084b/JOCD-20-18-g002.jpg

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